QMS METHODOLOGY

The GCI Quality Management System Methodology includes the following services and products:

• Quality and Project Planning

• Functional Requirements Definition

• Design Specifications

• Design Reviews

• Test Plans

• Traceability Matrices

• Functional (Black Box) Testing

• Structural (White Box) Testing

• Commissioning Reports

• System Development Life Cycle documentation

• Programming Standards

• Calibration Procedures

• System Performance and Acceptance Criteria

• Training Procedures and Work Instructions

• Security Procedures

• Decommissioning and Retirement Procedures

• Operation, Maintenance and Repair Procedures

• Change Control Procedures

• Configuration Management

• Multi-Vendor Systems Maintenance Procedures

• 21 CFR 11 Interpretation, Assessments and Remediation